TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 50 SUNSCREEN- homosalate, octinoxate, octisalate and zinc oxide lotion 
Allergan, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Total Defense Repair Broad Spectrum SPF 50 Sunscreen
Drug Facts

Active ingredients

Homosalate 6.0%

Octinoxate 7.5%

Octisalate 5.0%

Zinc Oxide 10.0%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

on damaged or broken skin 

When using this product

keep out of eyes. Rinse with water to remove. 

Stop use and ask a doctor

if rash occurs 

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away. 

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply after 80 minutes of swimming or sweating, at least every 2 hours, or after towel drying to avoid lowering protection
  • Sun Protection Measures UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun from 10 a m -2 p.m., and wearing protective clothing
  • children under 6 months: Ask a doctor

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Niacinamide, Silica. Glyceryl Stearate. PEG-100 StearatB. Ceteaiyl Alcohol. Squalane, Polygonum Aviculare Extract Physalis Angulata Extract, Dunaliella Salina Extract. Ubiquinone, Glycerin. Camellia Sinensis Leaf Extract Melanin, Tocopheryl Acetate, Tocopherol, Hydroxyacetophenone. Batyl Alcohol. C12-15 Alkyl Benzoate, Butylene Glycol. Ceteareth-20. Polyhydroxystearic Acid, Isostearic Acid, Acrylates Copolymer, Xanthan Gum, Ethylhexylglycerin, Disodium EDTA. Caprylyl Glycol, Sorbic Acid, Phenoxyethanol

Other information

  • protect the product in this container from excessive heat and direct sun
  • store at room temperature 15°- 30°C (59°- 86°F)

Questions or comments

www.skinmedica.com 

Principal Display Panel - Carton Label

TOTAL DEFENSE
+
REPAIR
Broad Spectrum SPF 50+ Sunscreen
Water Resistant (80 Minutes)
+ INFRARED PROTECTION
Net Wt. 6 x 1.0 Oz Travel

TOTAL DEFENSE 
+ 
REPAIR 
Broad Spectrum SPF 50+ Sunscreen
Water Resistant (80 Minutes)
+ INFRARED PROTECTION
Net Wt. 6 x 1.0 Oz Travel

TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 50 SUNSCREEN 
homosalate, octinoxate, octisalate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-5501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE60 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SQUALENE (UNII: 7QWM220FJH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
BATILOL (UNII: 39YR661C4U)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
UBIDECARENONE (UNII: EJ27X76M46)  
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0023-5501-031 in 1 CARTON06/15/201512/14/2021
185 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0023-5501-011 in 1 CARTON06/15/201512/14/2021
228.4 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0023-5501-256 in 1 CARTON06/15/201512/14/2021
37.08 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/15/201512/14/2021
Labeler - Allergan, Inc. (144796497)

Revised: 4/2013
 
Allergan, Inc.